Label: QUALITY CHOICE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 63868-356-14, 63868-356-28 - Packager: Chain Drug Marketing Association Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 5, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active ingredients Purpose
Bacitracin zinc 400 units................................................ First aid antibiotic
Neomycin sulfate 3.5 mg............................................... First aid antibiotic
Polymyxin B sulfate 5,000 units...................................... First aid antibiotic
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-356 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-356-14 1 in 1 CARTON 01/16/2015 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:63868-356-28 1 in 1 CARTON 01/16/2015 2 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/15/2015 Labeler - Chain Drug Marketing Association Inc (011920774)